Related Pages Breast Cancer Home Page 1 NCI's gateway for information about breast cancer. U.S. Task Force: Chemoprevention of Breast Cancer 2 The U.S. Preventive Services Task Force has issued two recommendations concerning the use of prescription medicines such as tamoxifen in the prevention of breast cancer. Estrogen Receptors, Tamoxifen, and Raloxifene 3 Describes the hormone estrogen and its receptor. Explains the relationship of estrogen and its receptor to breast cancer and the risks and benefits of reducing cancer risk with drugs called antiestrogens and selective estrogen receptor molecules (SERMs).

STAR Background

STAR-At-A Glance

STAR Enrollment Statistics

STAR Images

STAR Publications

Introduction

The Study of Tamoxifen and Raloxifene, or STAR, is a clinical trial designed see how the drug raloxifene compares with the drug tamoxifen in reducing the incidence of breast cancer in postmenopausal women who are at increased risk of the disease. (See a summary of the protocol ⁴.) One of the largest breast cancer prevention studies ever, STAR took place at more than 500 centers ⁵ across the United States, Canada, and Puerto Rico.

Initial results of STAR show that the drug raloxifene is as effective as tamoxifen in reducing the breast cancer risk of the women on the trial. In STAR, both drugs reduced the risk of developing invasive breast cancer by about 50 percent. In addition, within the study, women who were assigned to take raloxifene daily and who were followed for an average of about four years, had 36 percent fewer uterine cancers and 29 percent fewer blood clots than the women who were assigned to take tamoxifen. Uterine cancers, especially endometrial cancers, are a rare but serious side effect of tamoxifen. Both tamoxifen and raloxifene are known to increase a woman's risk of blood clots.

Researchers with the National Surgical Adjuvant Breast and Bowel Project (NSABP ⁶), an NCI-funded Cooperative Group, conducted the trial. STAR was funded primarily by NCI.

The links on the left of this page will take you to more detailed information about the trial and its results so far, including a variety of press materials (see STAR Background ⁷).

Breast cancer is a critical public health problem: more than 212,000 women will be diagnosed with breast cancer in the United States this year and more than 30,000 will die of the disease.

The following links will take you to press releases and other materials concerning the STAR trial that have been prepared by the National Cancer Institute's Office of Communications and Education.

Main Objective	STAR was designed to determine whether the osteoporosis drug raloxifene is as effective in reducing breast cancer risk as tamoxifen, with fewer side effects.
Enrollment Accrual Period	July 1999 – November 2004
Participants	A total of 19,737 women: 93.4% white 2.5% African American 2.0% Hispanic/Latina 2.1% other minorities
Intervention	Women were randomly assigned to take either 20 mg of tamoxifen and a placebo or 60 mg raloxifene and a placebo daily for five years.
Criteria for Participation	General good health 35 and over Women Postmenopausal at high risk for breast cancer based on the Gail risk model
Study Sites	More than 500 in the U.S., Puerto Rico and Canada.
Additional Study Objectives	Investigators are assessing rates of invasive breast cancer, noninvasive breast cancer, uterine cancer, deep vein thrombosis, pulmonary embolism, bone fractures, stroke, cataracts, ischemic heard disease, all other cancers, and overall deaths. Quality of life factors (including hot flashes, which both drugs can trigger) and cognitive function in older women are also being examined.

STAR Enrollment Statistics

The Study of Tamoxifen and Raloxifene (STAR) is a breast cancer prevention clinical trial designed to determine whether the osteoporosis prevention drug raloxifene (Evista®) is as effective as tamoxifen (Nolvadex®) in reducing breast cancer risk, with fewer side effects. The trial began enrolling participants in July 1999 and completed enrollment in November 2004 with 19,747 postmenopausal women at increased risk of breast cancer.

STAR Enrollment Data: Overview

• For STAR, 184,461 women went through the risk assessment process to determine their eligibility for the trial. Of these women, 96,368 were eligible for the trial because of their increased risk of developing breast cancer. Of those risk-eligible women, 19,747 chose to participate.

• Of the 19,747 women who joined STAR, 1,344 were from the placebo group of the Breast Cancer Prevention Trial (the study that compared tamoxifen to a placebo).

• The estimated breast cancer risk of women in STAR was substantially above the required minimum 1.66 percent risk of developing the disease within the next five years.

• Women joining STAR had to have been postmenopausal and at least 35 years of age. The ages of women joining STAR:

• 9.1 percent (1,792) of the women who joined STAR reported a previous diagnosis of lobular carcinoma in situ (LCIS), a condition that is not cancer, but which indicates an increased chance of developing invasive breast cancer.
  
  
• About half of the women who joined STAR had had a hysterectomy prior to enrolling (51.7 percent). Women who have had a hysterectomy are not at risk for endometrial cancer; tamoxifen can raise a woman's chance of developing that disease.
  
  
• The majority of women on STAR (71.2 percent) reported at least one close relative with breast cancer.
  
  
• Postmenopausal women of all races and ethnic backgrounds were encouraged to participate in STAR, and more than 6 percent of the women in STAR were from minority groups. A total of 38,910 women from minority groups went through the risk assessment process; 8,359 had an increased risk of breast cancer that would qualify them for the study; and 1,301 joined the trial.
  
  
• Among African-American participants, 21,444 went through the risk assessment process, 3,280 were risk-eligible, and 488 joined STAR. About 2.5 percent of STAR participants were African-American.
  
  
• Among Hispanic/Latina women, 7,913 went through the risk assessment process, 1,841 were risk-eligible, and 394 joined STAR. About 2.0 percent of the women on STAR were Hispanic/Latina.
  
  
• Among women who defined themselves as representing another minority population, such as Native American or Asian American, 9,553 have gone through the risk assessment process, 3,238 were rick-eligible, and 419 joined STAR. About 2.1 percent of the women on STAR were ethnic minorities other than African-American or Hispanic/Latina.
  
  
• For comparison, the Breast Cancer Prevention Trial - the predecessor study to STAR - had a total of 8,525 minority women go through the risk assessment process, 2,979 were risk-eligible, and 486 joined this 13,000-woman trial (about 4 percent of participants).

STAR Enrollment Data: By State and Province

Here is a table of enrollment data categorized by U.S. state (including Puerto Rico and the District of Columbia) and Canadian province.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) maintains a Web site with information about STAR, including a STAR Image Gallery ¹⁶. STAR Publications

The following citations are of reports that have been published in the scientific literature concerning the Study of Tamoxifen and Raloxifene (STAR). The citations are listed in reverse chronological order.

2006 Publications

Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial ¹⁷

• Authors: Land SR, Wickerham DL, Costantino JP, Ritter MW, Vogel VG, Lee M, Pajon ER, Wade JL 3rd, Dakhil S, Lockhart JB Jr, Wolmark N, Ganz PA
• Journal: Journal of the American Medical Association 2006 Jun 21;295(23):2742-51

Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial ¹⁸

• Authors: Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER Jr, Wade JL 3rd, Robidoux A, Margolese RG, James J, Lippman SM, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan VC, Wolmark N; National Surgical Adjuvant Breast and Bowel Project (NSABP)
• Journal: Journal of the American Medical Association 2006 Jun 21;295(23):2727-41

2003 Publications

A Review of Selective Estrogen Receptor Modulators and National Surgical Adjuvant Breast and Bowel Project Clinical Trials ¹⁹

• Author: Smith RE
• Journal: Seminars in Oncology 2003 October;30(5 Suppl 16):4-13

Chemoprevention of Breast Cancer and the Trials of the National Surgical Adjuvant Breast and Bowel Project and Others ²⁰

• Author: Smith RE, Good BC
• Journal: Endocrine-Related Cancer 2003 September;10(3)347-357

National Surgical Adjuvant Breast and Bowel Project Update: Prevention Trials and Endocrine Therapy of Ductal Carcinoma in Situ ²¹

• Author: Vogel VG, Costantino JP, Wickerham DL, Cronin WM
• Journal: Clinical Cancer Research 9(1 Pt 2):495S-501S, January 2003

2002 Publications

Tamoxifen Versus Raloxifene in the Prevention of Breast Cancer ²²

• Author: Wickerham DL
• Journal: European Journal of Cancer 2002; 38 (Suppl 6): S20-S21

The Study of Tamoxifen and Raloxifene: Preliminary Enrollment Data From a Randomized Breast Cancer Risk Reduction Trial ²³

• Author: Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Wolmark N
• Journal: Clinical Breast Cancer 3(2):153-159, June, 2002

2001 Publications

Benefit/Risk Assessment of SERM Therapy: Clinical Trial Versus Clinical Practice Settings ²⁴

• Author: Costantino JP
• Journal: Annals of the New York Academy of Sciences 949:280-285 December, 2001